What is known and objective: The validation of a method for recording pharmaceutical interventions measures the instrument’s ability to provide consistent values when the same analysis is performed ...several times. Our aim was to validate the inter‐rater reliability of the method used to record pharmaceutical interventions in our hospital.
Methods: We recorded interventions in a database, entering variables related to the patient, treatment and impact of the recommendation. We also recorded the type, cause and clinical significance of the negative outcome associated with use of the medicinal product (NOM). Twenty interventions performed during a 3‐year study period (2007–2009) were randomly tested for consistency to analyse the kappa (κ) coefficient statistic of the recommendations as coded by nine senior and junior clinical pharmacists.
Results and discussion: There were 87·8% global consistency for NOM cause, 66·1% for intervention impact and 95·0% for NOM type. Agreement was substantial for ‘intervention reasons’, with a κ value of 0·74 (95%CI 0·61–0·87), fair for ‘intervention impact’, with a κ value of 0·24 (95%CI 0·15–0·32) and excellent for ‘NOM type’, with a κ value of 0·87 (95%CI 0·71–1·00), respectively. Our results are globally good, especially with regard to the analysis of intervention reasons and NOM type, which matches other authors’ findings. Furthermore, our validation method is suitable for recording and considering the impact of pharmaceutical interventions.
What is new and conclusion: We describe a systematic method for clinical pharmacists to record their activities and assess their value. This methodology should help in the development of clinical pharmacy in Spain and should be translatable to other settings.
Background and ImportanceAllogeneic haematopoietic stem cell transplantation (allo-HCT) is the only curative therapy in patients with sickle cell disease (SCD). Conditioning regimens traditionally ...were busulfan based. Treosulfan shows advantages such as intense immunosuppressive activity, low extramedullary toxicity and linear pharmacokinetics that decreases variability.Aim and ObjectivesTo evaluate safety and potential complications associated to allo-HCT after treosulfan-based conditioning regimen in children with SCD.Material and MethodsRetrospective, observational, unicentric study. Inclusion criteria comprised paediatric patients diagnosed with SCD who had undergone allo-HCT at a tertiary hospital between April 2015 and September 2022. Conditioning regimen included thiotepa, treosulfan, fuldarabine and anti-thymocyte globulin. Variables: gender, age, age of diagnosis, age of allo-HCT, type of HCT, graft versus host disease (GvHD) prophylaxis, seizure prophylaxis, veno-occlusive disease (VOD) prophylaxis, cumulative incidence of GvHD, non-haematological toxicity (potentially associated to conditioning regimen) during the first 30 days after HCT, graft failure, peripheral blood chimerism data collected and death related to HCT. Disease-free survival and overall survival after HCT were also measured.Results31 patients were included in the study (17 female, 14 male). Median age of diagnostics was 2 months (2–120) and median age of allo-HCT was 64 months (25–154). Median time between diagnostic and HCT was 4 years (1.9–12.5). Transplantation was the first for all children except for one (graft failure after a previous allo-TPH). All donors were human leucocyte antigen (HLA)-matched siblings. Double-therapy immunosuppression was used in GvHD prophylaxis (21/31 cyclosporine with mycophenolate mofetil and 10/31 tacrolimus with mycophenolate mofetil). All received levetiracetam and ursodeoxycholic acid for seizure and VOD prophylaxis, respectively.11/31 developed cutaneous GvHD (10 grade I-II and 1 grade III-IV) and 2/31 grade I-II hepatic GvHD. 4/31 developed grade I-II mucositis and 4/31 grade III-IV mucositis. 3/31 cases of mild diarrhoea, 5/31 neurological toxicities (seizures and encephalopathy) and 1/31 case of hepatomegaly (not associated to VOD) were registered. All resolved adequately. 25/31 children showed complete chimerism in peripheral blood at the end of follow-up. Immunosuppression was enhanced in case of mixed chimerism .There were no graft failures. All children are alive and remain disease-free after median follow-up of 47 months (12–78).Conclusion and RelevanceTreosulfan-based conditioning shows clinically manageable toxicity profile and low morbidity and mortality.References and/or AcknowledgementsConflict of InterestNo conflict of interest
Summary
Background/objective
Pharmaceutical care is needed in hepatitis C virus (HCV)‐infected patients treated with direct‐acting antivirals (DAA). We describe the implementation of a comprehensive ...pharmaceutical care programme (CPCP) for HCV‐infected patients treated with DAA in a tertiary‐care hospital and provide data about health outcomes and costs.
Methods
Quasi‐experimental study between 1 April 2015 and 30 June 2016. A group of hospital pharmacists collaborating on HCV infection implemented interventional measures for validation of drug prescriptions, detection of clinically relevant drug‐drug interactions and adverse drug events (ADEs), and patient education. Quality, health and cost‐effectiveness outcomes were evaluated.
Results
A total of 1070 patients were enrolled. Pharmacists made 327 interventions that led to the prevention of 299 (91.4%) medication errors, 16 of which were grade G‐H (NCC MERP classification). The main reasons for the pharmacist's intervention were management of 143 drug‐drug interactions. The overall sustained virologic response at week 12 posttreatment (SVR12) rate was 93.0% (95% CI 91.4‐94.6). The SVR12 was higher than 90.0% in all populations, except in genotype 3 patients (86.0%, 95% CI 78.7‐93.9), decompensated cirrhotic patients (81.1%, 95% CI 69.7‐92.6) and transplant recipients (86.8%, 95% CI 76.7‐96.9). ADEs occurred in 85.5% of the study patients, but only 1.0% (11 patients) experienced an ADE that led to premature discontinuation. The total cost of treatment was €18 279 225 (€17 083 per patient). The most cost‐effective treatment was selected in 93.1% of patients.
Conclusions
The implementation of a CPCP developed by hospital pharmacists in patients treated with DAAs for HCV infection is an effective approach that improves patient safety and education. The active involvement of the pharmacist in improving adherence to local guidelines promoted the selection of the most cost‐effective treatment in the majority of cases.
Abstract Objectives To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted. Design Observational, ...prospective study carried out from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital. Setting A tertiary level hospital pediatric intensive care unit. Participants Infusions delivered with infusion pumps in all pediatric intensive care unit patients. Interventions Design of a drug library with safety limits for all intravenous drugs prescribed. Main variables Users’ compliance with drug library as well as number and type of errors prevented were analyzed. Results Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users’ average compliance with the safety software was 84%. Conclusions Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process.
BackgroundLimited data are available regarding co-administration of acenocoumarol with direct acting antiviral agents.PurposeWe report a case of a patient who required a significant increase in the ...acenocoumarol weekly dose when co-administered with ombitasvir/paritaprevir/ritonavir.Material and methodsData on international normalised ratio (INR), acenocumarol dosing and concomitant medications were obtained from the general practitioner. Potential drug-drug interactions were checked using Lexi-Comp, SPC and www.hep-druginteractions.org ResultsA 61-year-old-male with treatment naïve genotype 1a chronic hepatitis C was examined in the gastroenterology department. His baseline viral load was 2 893 236 IU/mL and he had compensated liver cirrhosis.His medical record included rheumatic valvulopathy that required double valve replacement and anticoagulation with acenocoumarol 8 mg/week (target INR 2.5–3.5). His INR had been stable on a dose of 8–9.5 mg/week over the past 2 years. Concomitant medications included omeprazole 20 mg/24 h, lisinopril 5 mg/24 h, digoxin 0.125 mg/24 h, bisoprolol 2.5 mg/24 h and furosemide as needed. Omeprazole interacts with acenocoumarol but increases its effect. Concomitant medications had not been modified for several months.He started antiviral treatment in April 2015 with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg/24 h, dasabuvir 250 mg/12 h and ribavirin 400 mg/12 h for 24 weeks. His baseline INR was 3. After evaluating potential interactions, the gastroenterologist recommended close digoxin and INR monitoring.At week 4, the INR became subtherapeutic at 1.4. Therefore, the acenocoumarol dose was increased to 11 mg/week and enoxaparin 100 mg/24 h was started.At week 6, the INR was 1.6 and the dose was titrated to 13 mg/week. Enoxaparin was reduced to 60 mg/24 h.At week 9, the INR was 1.9 and the dose was increased to 16.5 mg/week.At week 12, the INR was 2.1 and the dose was increased to 19.5 mg/week. Enoxaparin was withheld.At week 16, the INR was 2.3 and the dose was titrated to 20.5 mg/week.At week 24,the INR was 3.8 and the dose was decreased to 19 mg/week.At the end of treatment, the acenocoumarol dose had been increased by 137.5%.During the 24 week period, the patient reported no compliance problems, treatment modifications or dietary changes. He did not experience any thrombotic or bleeding event.A causality assessment was conducted according to the Naranjo algorithm and the score obtained was 5 (adverse drug reaction classified as probable).ConclusionThere is a possibility of decreased INR after concomitant use of acenocoumarol and ombitasvir/paritaprevir/ritonavir.No conflict of interest.
Background and ImportanceOral administration of injectables is an alternative for patients with difficulties tolerating solid pharmaceutical forms.Due to their physicochemical characteristics not ...adapted to oral administration, gastrointestinal adverse effects can occur, especially in patients with transpyloric feeding tube, especially when they have an osmolarity >500 mOsm/L or pH <3.5.Aim and ObjectivesThe aim of the present work is to characterise the physicochemical properties of injectable formulations commonly used orally and their gastrointestinal absorption site in order to increase safety in their administration by transpyloric feeding tube.Material and MethodsA literature search was conducted to establish the gastrointestinal absorption site of the active principles (AP) analysed.For each preparation, pH and osmolality were experimentally determined. The pH was measured with a pH meter (Crison 2006, Hach Lange España, S.L.U., Spain). Osmolarity was determined using the Fiske Model 210 Micro Osmometer (John Morris Scientific Pty Ltd., Australia), considering the density of the active principles studied to be equal to 1 mg/ml. All measurements were performed in triplicate.ResultsOf the 24 APs analysed, pH values<3.5 were found in 21% of preparations, which discourages transyejunal administration. In addition, 25% of the formulas administered had osmolarity >500 mOsm/L.Of the 13 APs that have bioavailability by transpyloric route, only eight are adequately formulated for this, and another three could be diluted prior to administration to avoid high osmolarities.Of the five APs that cannot be administered via the transpyloric route, three of them are also not adequately formulated.Of the remaining six APs, whose absorption site cannot be objectified, three have good physicochemical characteristics and with another two this could be achieved by diluting with water.Conclusion and RelevanceMost of APs studied, the gastrointestinal absorption of the drug is not sufficiently characterised, leading to uncertainty when administered by transpyloric feeding tube.Many of the injectables have a high osmolarity and therefore require prior dilution, while the pH values of some of them can be an added factor for the development of digestive intolerances.References and/or AcknowledgementsConflict of InterestNo conflict of interest.
Therapeutic management of inborn errors of metabolism (IEMs) is complicated. The drugs involved are classified as orphan, and their supply depends on whether they are orphan medicines, ...investigational drugs, or need to be prepared as a compounded formula.
We analyzed emergency criteria, availability, and permanent location of metabolic drugs within the hospital. Information on therapeutic usage, administration, and dosage was also recorded.
A stock for treating IEMs should include chelating agents, drugs to treat deficiencies, enzyme supplements, and other specific treatments. Hyperammonemia was considered to be life-threatening; therefore, an emergency supply of drugs to treat this condition should be kept permanently in the hospitalization unit.
Emergency drug stocks are highly recommended in tertiary hospitals in order to improve care for patients susceptible to IEM.
To estimate the impact of smart pump implementation in a pediatric intensive care unit in terms of number and type of administration errors intercepted.
Observational, prospective study carried out ...from January 2010 to March 2015 with syringe and great volumen infusion pumps available in the hospital.
A tertiary level hospital pediatric intensive care unit.
Infusions delivered with infusion pumps in all pediatric intensive care unit patients.
Design of a drug library with safety limits for all intravenous drugs prescribed.
Users' compliance with drug library as well as number and type of errors prevented were analyzed.
Two hundred and eighty-three errors were intercepted during 62 months of study. A high risk drug was involved in 58% of prevented errors, such as adrenergic agonists and antagonists, sedatives, analgesics, neuromuscular blockers, opioids, potassium and insulin. Users' average compliance with the safety software was 84%.
Smart pumps implementation has proven effective in intercepting high risk drugs programming errors. These results might be exportable to other critical care units, involving pediatric or adult patients. Interdisciplinary colaboration is key to succeed in this process.
Resumen La infección por citomegalovirus es frecuente en pacientes trasplantados cardiacos. Foscarnet se utiliza, con evidencia limitada, como tratamiento de segunda línea tras el fracaso de ...ganciclovir en estos pacientes. Presentamos un caso de alteraciones electrolíticas por foscarnet administrado para el tratamiento de infección por citomegalovirus en un paciente pediátrico trasplantado cardiaco. La infección se resolvió tras 6 semanas de tratamiento, apareciendo niveles de calcio iónico bajos durante la infusión del fármaco e hipomagnesemia mantenida tratada con suplementos, que revirtieron al retirar el fármaco.
PDF
